Physicians' Academy for Cardiovascular Education

ESC 0/1-hour hs-cTnT algorithm does not safely exclude 30-day cardiac events in known CAD

Performance of the European Society of Cardiology 0/1-Hour Algorithm With High-Sensitivity Cardiac Troponin T Among Patients With Known Coronary Artery Disease

Literature - Ashburn NP, Snavely AC, O’Neill JC, et al. - JAMA Cardiol. 2023 Apr 1;8(4):347-356. doi: 10.1001/jamacardio.2023.0031

Introduction and methods

Background

The European Society of Cardiology (ESC) 0/1-hour algorithm is an accelerated diagnostic protocol that is designed to rapidly rule in or rule out NSTEMI based on hs-cTnT level [1]. Previous studies, which were conducted primarily in Europe, showed that with this algorithm, almost 60% of patients are classified as “rule-out”, with a negative predictive value (NPV) of ≥99% [2-8]. However, limited data exist regarding its performance in patients with known coronary artery disease (CAD), particularly in a US cohort of chest pain patients.

Aim of the study

The study objectives were: (1) to determine whether the ESC 0/1-hour hs-cTnT algorithm could achieve the NPV threshold of 99% required to safely rule out 30-day cardiac death or MI among patients with known CAD; and (2) to evaluate and compare the diagnostic performance of this algorithm for 30-day MACE in patients with and with no known CAD.

Methods

This was a preplanned subgroup analysis of the STOP-CP (High-Sensitivity Cardiac Troponin T (Gen 5 STAT assay) to Optimize Chest Pain Risk Stratification) study. In this prospective multicenter cohort study, patients aged ≥21 years with acute chest pain or other ACS-related symptoms were enrolled at 8 (mostly academic) emergency departments in the USA. Presence of STEMI was an exclusion criterion. Known CAD—defined as prior MI, coronary revascularization, or coronary stenosis ≥70%—was determined by medical record review and patient self-reporting. In this analysis, 1430 patients were included, of whom 449 (31.4%) had known CAD.

Serial blood samples were collected for hs-cTnT measurement at baseline and 1 hour thereafter. hs-cTnT results were used to stratify patients into 3 zones: rule-out (0-hour hs-cTnT<6 ng/L or 0-hour <12 ng/L and ∆0/1-hour <3 ng/L), observation (any hs-cTnT value or ∆ not meeting rule-out or rule-in criteria), and rule-in (0-hour hs-cTnT ≥52 ng/L or ∆0/1-hour ≥5 ng/L). Treating clinicians were blinded to the hs-cTnT results, and patient care was guided by contemporary cTn results.

Outcomes

The primary endpoint was cardiac death or MI at 30 days. Secondary endpoints included MACE (defined as cardiac death, MI, or coronary revascularization) at 30 days; individual MACE subcomponents; and efficacy (defined as proportion of patients classified into rule-out zone).

Main results

Rule-out zone

Rule-in zone

Interaction between algorithm classification and known CAD

Conclusion

In this preplanned subgroup analysis of the observational STOP-CP study, the ESC 0/1-hour hs-cTnT algorithm had an NPV below the accepted 99% threshold for 30-day cardiac death or MI in patients presenting at a US emergency department with acute chest pain or other ACS-related symptoms who had a history of CAD. Although the NPV was significantly higher in patients with no known CAD, it still did not meet the threshold. An NPV <99% was also observed for 30-day MACE in both patient groups. According to the authors, their results suggested the ESC 0/1-hour hs-cTnT algorithm “is likely not safe for routine use among US patients with chest pain [in the emergency department], regardless of CAD status.”

References

Show references

Find this article online at JAMA Cardiol.

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